Drugs

‘Objectionable Conditions’ in Dr. Adnan Dahdul's Clinical Trial

FDA says a 5/6-6/20/2024 Bioresearch Monitoring Program inspection of a clinical investigation conducted by Dr. Adnan Dahdul in Springfield, MA, found “objectionable conditions” in that Dahdul violated regulations governing the proper conduct of clinical studies involving investigational products. A just-released 3/12 Warning Letter says the specific violations were:

failure to obtain legally effective informed consent;
failure to ensure the investigation was conducted according to the signed statement of the investigator and the investigational plan; and
failure to prepare and maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.

Dahdul was told to explain how he intends to rectify the issue of lack of oversight and proper supervision of research staff and to detail his procedure to ensure contemporaneous review and remediation of the observations affecting the accuracy and adequacy of data and information necessary to reconstruct a complete picture of the study conduct. He is also to provide all documentation of the processes for verifying the accuracy and completeness of the data.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome